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May 6, 2021

CytoDyn and AEIH to begin trials of leronlimab in severe Covid-19

CytoDyn and academic research organisation (ARO) Albert Einstein Israelite Hospital (AEIH) are set to commence two Phase III trials of HIV drug leronlimab (Vyrologix or PRO 140) in patients with severe Covid-19 in São Paulo, Brazil.

This development is part of CytoDyn’s agreement to collaborate with AEIH to carry out the trials in up to 45 clinical sites in the country.

These Phase III trials are anticipated to deliver the data required by the Brazilian regulatory authority, ANVISA, to make leronlimab available for Covid-19 patients in the country.

The company plans to carry out interim analysis in October and November when the trial enrols 120 critically ill patients or 40% of the 300 subjects.

CytoDyn chief operating officer and Clinical Development head Chris Recknor said: “This ARO has conducted multiple large-scale Covid trials for many pharmaceutical companies. CytoDyn is utilising their extensive experience to develop and conduct our CD16 and CD17 Covid-19 trials.

“With approximately 1,500 patients in total for both trials, we anticipate having adequate power in each trial to achieve a significant p-value for our endpoints and will be performing an interim analysis after 40% of the critically ill patients are enrolled.”

An investigational humanised IgG4 monoclonal antibody, leronlimab hinders C-C chemokine receptor type 5 (CCR5), a cellular receptor vital in HIV infection, tumour metastases and various diseases.

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Leronlimab has so far been analysed in 11 clinical trials in over 1,200 individuals. It met primary endpoints in a Phase III trial, when combined with standard antiretroviral therapies in HIV patients who are treatment-experienced.

In nine clinical trials, leronlimab was found to considerably lower or regulate HIV viral load in people.

The leronlimab antibody is considered an antiviral agent with less side effects and reduced dosing requirements compared to existing daily drug treatme.

Last month, CytoDyn and Biomm signed an exclusive supply and distribution agreement that will enable the latter to market leronlimab in Brazil on receiving regulatory approval.

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